Cargando…

Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less...

Descripción completa

Detalles Bibliográficos
Autores principales: Favresse, Julien, Gillot, Constant, Oliveira, Maxime, Cadrobbi, Julie, Elsen, Marc, Eucher, Christine, Laffineur, Kim, Rosseels, Catherine, Van Eeckhoudt, Sandrine, Nicolas, Jean-Baptiste, Morimont, Laure, Dogné, Jean-Michel, Douxfils, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828347/
https://www.ncbi.nlm.nih.gov/pubmed/33450853
http://dx.doi.org/10.3390/jcm10020265
_version_ 1783640989845422080
author Favresse, Julien
Gillot, Constant
Oliveira, Maxime
Cadrobbi, Julie
Elsen, Marc
Eucher, Christine
Laffineur, Kim
Rosseels, Catherine
Van Eeckhoudt, Sandrine
Nicolas, Jean-Baptiste
Morimont, Laure
Dogné, Jean-Michel
Douxfils, Jonathan
author_facet Favresse, Julien
Gillot, Constant
Oliveira, Maxime
Cadrobbi, Julie
Elsen, Marc
Eucher, Christine
Laffineur, Kim
Rosseels, Catherine
Van Eeckhoudt, Sandrine
Nicolas, Jean-Baptiste
Morimont, Laure
Dogné, Jean-Michel
Douxfils, Jonathan
author_sort Favresse, Julien
collection PubMed
description (1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.
format Online
Article
Text
id pubmed-7828347
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-78283472021-01-25 Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection Favresse, Julien Gillot, Constant Oliveira, Maxime Cadrobbi, Julie Elsen, Marc Eucher, Christine Laffineur, Kim Rosseels, Catherine Van Eeckhoudt, Sandrine Nicolas, Jean-Baptiste Morimont, Laure Dogné, Jean-Michel Douxfils, Jonathan J Clin Med Article (1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients. MDPI 2021-01-13 /pmc/articles/PMC7828347/ /pubmed/33450853 http://dx.doi.org/10.3390/jcm10020265 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Favresse, Julien
Gillot, Constant
Oliveira, Maxime
Cadrobbi, Julie
Elsen, Marc
Eucher, Christine
Laffineur, Kim
Rosseels, Catherine
Van Eeckhoudt, Sandrine
Nicolas, Jean-Baptiste
Morimont, Laure
Dogné, Jean-Michel
Douxfils, Jonathan
Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title_full Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title_fullStr Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title_full_unstemmed Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title_short Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
title_sort head-to-head comparison of rapid and automated antigen detection tests for the diagnosis of sars-cov-2 infection
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828347/
https://www.ncbi.nlm.nih.gov/pubmed/33450853
http://dx.doi.org/10.3390/jcm10020265
work_keys_str_mv AT favressejulien headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT gillotconstant headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT oliveiramaxime headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT cadrobbijulie headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT elsenmarc headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT eucherchristine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT laffineurkim headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT rosseelscatherine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT vaneeckhoudtsandrine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT nicolasjeanbaptiste headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT morimontlaure headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT dognejeanmichel headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection
AT douxfilsjonathan headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection